Xylocaine — Class II drug recall D-0728-2026
Ongoing recall by Fresenius Kabi USA, LLC, reported 2026-07-29, distributed nationwide. Presence of Particulate Matter: Hair was found in products
| Recall number | D-0728-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA, LLC, Lake Zurich, IL, United States |
| Recall initiated | 2026-07-16 |
| Classified | 2026-07-23 |
| Reported by FDA | 2026-07-29 |
| Distributed | Nationwide (US) |
| Quantity | 93,250 vials |
| Reason classes | specification failure |
| NDC | 63323-0481, 63323-0481-01, 63323-0481-57, 63323-0482, 63323-0482-01, 63323-0482-03, 63323-0482-05, 63323-0482-17, 63323-0482-27, 63323-0482-57, 63323-0483, 63323-0483-01, 63323-0483-03, 63323-0483-27, 63323-0483-57, 63323-0484, 63323-0484-57, 63323-0485, 63323-0485-01, 63323-0485-03, 63323-0485-27, 63323-0485-57, 63323-0486, 63323-0486-01, 63323-0486-02 and 42 more |
| Lot numbers | 6130235 |
| Expiration dates | 2027-02 |
Product
Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-27; NDC Vial: 63323-485-01
Reason for recall
Presence of Particulate Matter: Hair was found in products
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0728-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.